Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 18-85 years old inclusive

• Subarachnoid hemorrhage diagnosed by CT on admission

• Randomizable within 732 hours of subarachnoid hemorrhage

• Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)

• Surgical or endovascular obliteration

• Able to obtain written informed consent from patient or surrogate

Exclusion Criteria:

• Pregnancy, as confirmed by routine urine test on admission

• Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal

• On Statins, niacin, or fibrate therapy within 30 days of presentation

• Any vasospasm on the initial diagnostic angiogram

• Glasgow Coma Scale 5 or less at the time of randomization

• History of liver disease or active liver disease

• Hypersensitivity to statins

• Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label